Senior Manager, Patient Support – Quality Assurance

TG Therapeutics, Inc.; Morrisville (NC); Remote; USD 100,000 - 130,000; Full time

Job summary

A biotechnology company is seeking a Senior Manager for Patient Support focusing on Quality Assurance. This remote role involves developing strategies to enhance patient experiences, ensure compliance, and lead audits within the Patient Support Program. The ideal candidate will have over 7 years of experience in the biopharmaceutical industry, excellent communication skills, and a background in managing compliance within similar programs. This position includes moderate travel and offers a dynamic work environment for a dedicated professional.

Qualifications

• 7+ years of biopharmaceutical industry experience in MS with proven history.
• Knowledge of compliance and regulatory environment for Patient Support Programs.
• Experience in managing Patient Support Program related audits.

Responsibilities

• Develop Quality Assurance strategy for the Patient Support department.
• Monitor Patient Support call interactions with patients and healthcare providers.
• Lead programmatic audits to ensure program compliance.

Skills

Biopharmaceutical industry experience in MS

Knowledge of biologics and specialty products

Strong analytical competence

Excellent verbal and written communication skills

Education

BS or BA

Job description

Title: Senior Manager Patient Support – Quality Assurance

Location: Remote

If you are interested in the below position, please send your resume [e-mail] and REFERENCE THE POSITION TITLE within the subject line.

Organizational Overview

TG Therapeutics is a fully integrated, commercial stage, biotechnology company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.

Role

This position will develop and lead the Quality Assurance workstream for TG Therapeutics Patient Support Program. Reporting to the Executive Director, the Sr. Manager will be responsible for developing tactical Quality Assurance execution initiatives. The Sr. Manager will partner with the Patient Support Program Leadership Team, Legal, Compliance, Privacy teams to implement compliant program Business Rules, SOPs and processes and ensure all programs and services are performed in accordance with TG Therapeutics compliance policies.

Key Responsibilities

• Develop Quality Assurance strategy for the Patient Support department and support the development of program related strategies and tactics that enhance the MS patient experience
• Regularly monitor Patient Support call interactions with patients, care partners, healthcare providers, pharmacies, payers, etc. and evaluate accuracy and adherence to Program Business Rules and SOPs and report findings to the TG Compliance team
• Collaborate with vendor partner to ensure compliance with program Business Rules and SOPs; track and report discrepancies with business rules
• Proactively identify risks (i.e. workflow gaps) and develop and implement solutions to address the risks
• Lead programmatic audits to ensure program compliance and accuracy, investigate the root cause of human or systematic errors or mistakes, and implement a Corrective Action Plan to address; confirm Corrective Action Plans are completed in a timely manner
• Monitor Patient satisfaction survey responses and incorporate patient experiences into quality improvement efforts; partner with marketing on output of patient experience survey
• Focus on operational efficiency by optimizing workflows and tracking and reducing case escalations; assist with managing the escalation response time
• Contribute to the development, implementation and maintenance of the Business Rules and Standard Operations Procedures
• Analyze program operating trends to identify opportunities for process/program improvement. Routinely suggest and execute process improvements that positively impact the customer experience
• Monitor reimbursement and access policies and trends to ensure continuity of business planning, issues management, and associated plans of action to anticipate future requirements
• Partner internally with PV Quality and Quality Systems team on GxP Supplier Auditing requirements and findings. Collaborate on a PV Corrective Action Plan to address audit findings
• Participate and observe monthly call calibrations; identify gaps or discrepancies and determine action plan; reconcile and report findings with TG Legal and Compliance
• Track and trend noncompliance with program Business Rules and SOPs and streamline communication and documentation with TG legal/compliance
• Manage CAPA process with Vendor partners
• Track program/business rule changes for historical context along with documentation of those updates
• Participate and observe free goods reconciliation, free goods and copay audit process; identify gaps or discrepancies and determine action plan

Professional Experience/Qualifications

• 7+ years of biopharmaceutical industry experience in MS, with a proven history of increasing responsibilities and accomplishments
• Previous experience working closely with buy-and-bill products. Strong knowledge of biologics and specialty products
• In-depth knowledge of the compliance and regulatory environment for manufacturer Patient Support Programs
• Subject matter expertise managing and overseeing Patient Support Program related audits
• Excels in establishing clear performance objectives and evaluation criteria
• Must Demonstrate strong analytical competence
• Handles customer complaints with tact and diplomacy
• Ability to prioritize, manage and successfully complete a wide range of projects in an organized manner
• Proactively takes initiatives where project/program gaps are identified
• Excellent verbal and written communication skills with demonstrated ability to communicate clearly and effectively
• Passionate, flexible, and customer focused
• Meets organizational cost objectives and excels in making resource-allocated decisions
• This position requires moderate travel (25-30%)

Education

• BS or BA required.

TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.